Randomized Controlled Trial of Theranova Versus High-flux Dialyzer on Preservation of REsidual RenAl Function in Incident HemoDialysis Patients (THREAD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change of glomerular filtration rate
研究概览
简要总结
Theranova is a novel medium cut-off dialyzer and has better performance for removal of middle molecules compared to conventional hemodialysis. The study investigates the effect of Theranova dialzyer on preserving residual renal function in the incident hemodialysis pateitns compared to high-flux dialzyer. The primary endpoint is change of glomerular filtration rate, calculated using creatinine and urea clearance. The secondary endpoints are serial changes of glomerular filtration rate and daily urine volume, changes of serum middle molecule concentrations, hospitalization, mortality, and patient reported outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Incident end-stage renal disease ESRD patient receiving hemodialysis for less than 1 month
- •18 years old and older
- •Creatinine clearance of more than 2 ml/min
- •Agreement to participate in the clinical study
- •Vascular access by arteriovenous fistula/graft
排除标准
- •Plan for kidney transplantation within 6 months
- •Severe volume overloading state
- •Dialysis through permanent catheter
- •Any hematologic malignancy or monoclonal gammopathy
- •Any malignancy
- •Active infectious disease
- •HIV infection
- •Patient enrolled to another study within 3 month from starting the present study
研究组 & 干预措施
MCO group
Hemodialysis using Theranova 400 dialyzer
干预措施: Theranova 400 dialyzer (Device)
High-flux group
Hemodialysis using high-flux dialyzer (Fx CorDiax 80; Fresenius Medical Care)
干预措施: High-flux dialyzer (Device)
结局指标
主要结局
Change of glomerular filtration rate
时间窗: Between baseline and 12 months
Glomerular filtration rate is calculated as the mean of creatinine and urea clearance adjusted for body surface area. The outcome refers to the mean difference of glomerular filtration rate between baseline and after 12 months.
次要结局
- Change of daily urine volume(0, 3, 6, 9, 12 months)
- Change of hs-CRP(0, 12 months)
- Change of kidney injury markers(0, 12 months)
- Mortality(Through 12-month study duration)
- Change of glomerular filtration rate(0, 3, 6, 9, 12 months)
- Change and reduction ratio of inflammatory marker levels(0, 12 months)
- Change of cystatin-C(0, 12 months)
- Change and reduction ratio of Kappa and lambda free light chains(0, 12 months)
- Patient-reported outcome(0, 12 months)
- Change of Beta 2-microglobulin(0, 12 months)
- Hospitalization(Through 12-month study duration)
研究者
Yong-Lim Kim
M.D., Ph.D.
Kyungpook National University Hospital